UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Study of Throid and Iron-Sulfur states in CKD
Title of the study (Brief title)	TIS study
Region	Japan

Condition
Condition	chronic kidney disease (nondialyzed, dialyzed)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether dysregulation of sulfur amino acid, iron and vitamins affect thyroid function and oxidative stress/atherogenesis in patients with chronic kidney diease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	metabolism of sulfur amino acid, iron and vitamins. thyroid function. factors of atherogenesis.
Key secondary outcomes	samples: blood, urine, peritoneal effluent, hair. factors of metabolism of sulfur amino acids (homocystein, cystein), iron (ferritin, hepcidin, transporters), thiocyanate (cyanide, thiosufate, sulfate), thyroid function (T3/4, fT3/4, TSH, anti-thyroglobulin antibody, lipid), inflammation/oxidative stress (CRP, cytokines, peroxidase, MDA, ROS, GSH), markers of cell damage (growth factors, CA125), atherosclerosis (chest X ray, echo, ABI, PWV), cardiovascular events (cardiovascular death, renal failure, total death, admission), others (nutritional status, vitamins, vintage of dialysis, beta2-microglobulin, hemoglobin)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1)kidney disease, require medical care 2)Followed in the outpatient of our hospital and associated clinic 3)Expected survival time is more than 6 months 4)Aged 20 to 90 years 5)Fully informed consent was obtained
Key exclusion criteria	1)Malignancy 2)Malnutrition 3)Active inflammatory or infectious disease 4)Uncontrollable diabetes mellitus 5)Abdominal ascites or pleural effusion 6)Pregnancy 7)Judged inappropriate for this study by the physicians
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Division of Nephrology and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Japan
TEL	0798-45-6521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Yukiko Hasuike
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Division of Nephrology and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Japan
TEL	0798-45-6521
Homepage URL
Email	jin@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫医科大学病院

Other administrative information
Date of disclosure of the study information	2007 Year 11 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 09 Month 02 Day
Anticipated trial start date	2007 Year 10 Month 01 Day
Last follow-up date	2009 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	influence of clinical parameters on progress of atherosclerosis and cumulative survival, prospective study

Management information
Registered date	2007 Year 11 Month 27 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000820